Personalized Medicine: Identifying the Appropriate Patient through Biomarkers in Oncology

The first in a series of topics of interest for the managed care community, this brief discusses the value of biomarkers that can complement or replace existing screening tools to detect cancer at an early stage and, therefore, guide optimum treatment. A history of biomarkers is included as well as a detailed discussion about trastuzumab (Herceptin®), developed with the support of biomarkers, and new biomarkers in development.

Comparative Effectiveness Research: Paving the Way for Evidence-Based Decision Making

The second in a series of topics of interest for the managed care community, this brief details the background of comparative effectiveness research (CER) in the United States and discusses the goals versus the uses of CER and the importance of collecting real-world data to support evidence-based medicine. Included are examples of the effective use of CER in clinical practice.

Prostate cancer is the second leading cause of cancer death in men in the United States. According to the American Cancer Society an estimated 240,890 new cases of prostate cancer will be diagnosed in 2011 and 33,270 men will die from the disease. Immunotherapy is a form of biologic treatment that uses a therapeutic vaccine derived from cells in a patient’s own immune system to induce an antitumor response. Sipuleucel-T (Provenge), the first autologous cellular immunotherapy approved by the U. S. Food and Drug Administration, improves survival in men with asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer. This Clinical Brief discusses the epidemiology, natural history, and risk factors for prostate cancer, current diagnosis and treatment modalities, and the emergence of immunotherapy as a novel treatment to improve survival in men with advanced disease. Roger Muller, MD, FACEP, comments on managed care considerations. Safety information and full prescribing information for Sipuleucel-T are also provided.